BLUE SAIL INNOVATION— 510(k) K102161

Name: FDA 510(k) clearance K102161
Creator: U.S. Food and Drug Administration
Published: 2010-10-08

Substantially Equivalent

Shandong Blue Sail Innovation Co., Ltd.

FDA 510(k) clearance K102161 for BLUE SAIL INNOVATION, Substantially Equivalent on 2010-10-08. Applicant: Shandong Blue Sail Innovation Co., Ltd.. Device class: 1.

Clearance details

Applicant: Shandong Blue Sail Innovation Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2010-08-02
Decision date: 2010-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weifang, Shandong, CN

Download summary PDF View on FDA.gov ↗

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